Olmesartan medoxomil and hydrochlorothiazide

What is Olmesartan medoxomil and hydrochlorothiazide?

• Olmesartan medoxomil and hydrochlorothiazide (Benicar HCT) is a combination of olmesartan, an angiotensin II receptor blocker and hydrochlorothiazide, a thiazide diuretic used for the treatment of hypertension, to lower blood pressure.

Olmesartan medoxomil metabolism

Olmesartan structure 01

Hydrochlorothiazide

What are the uses of this medicine?

• Olmesartan medoxomil and hydrochlorothiazide (Benicar HCT) is used for the treatment of hypertension, to lower blood pressure.
• Benicar HCT is not indicated for the initial therapy of hypertension.
• Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

How does this medicine work?

Olmesartan medoxomil:

• Olmesartan (ol" me sar' tan) is an angiotensin II receptor blocker (ARB) used alone or in combination of other agents for therapy of hypertension.
• Olmesartan inhibits the renin-angiotensin system by blocking the angiotensin II type 1 receptor (AT1), which prevents the vasoconstriction and volume expansion induced by circulating angiotensin II which accounts for its antihypertensive activity.

Hydrochlorothiazide:

• Hydrochlorothiazide is a thiazide diuretic.
• Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts.
• Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium.
• The renin-aldosterone link is mediated by angiotensin II, so co-administration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with these diuretics.
• The mechanism of the antihypertensive effect of thiazides is not fully understood.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with hypersensitivity to any component of Benicar HCT.
• with anuria.
• coadministration with aliskiren in patients with diabetes

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention the following:

• Lithium
• Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)
• aliskiren
• colesevelam hydrochloride
• oral agents and insulin
• Ion exchange resins (e.g., cholestyramine, colestipol)
• Corticosteroids

Is this medicine FDA approved?

• Initial U.S. Approval: 2003
• No generic version is available in the United States as of 2017.
• In 2020, it was the 281st most commonly prescribed medication in the United States, with more than 1 million prescriptions.

How should this medicine be used?

Recommended dosage:

• The recommended starting dose of Benicar HCT is 40/12.5 mg once daily in patients whose blood pressure is not adequately controlled with olmesartan monotherapy.
• Dose can be titrated up to 40 /25 mg if necessary.

• The recommended starting dose of Benicar HCT is 20/12.5 mg once daily in patients whose blood pressure is not adequately controlled with HCT monotherapy or who experience dose-limiting adverse reactions with hydrochlorothiazide.
• Dose can be titrated up to 40 /25 mg if necessary.

Administration:

• Benicar HCT is available for oral administration in tablets must be taken once daily.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: (olmesartan medoxomil and hydrochlorothiazide) 20/12.5 mg; 40/12.5 mg; 40/25 mg

This medicine is available in fallowing brand namesː

• Benicar HCT

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• hyperuricemia
• dizziness
• upper respiratory infection

Benicar HCT may cause serious side effects which may include:

• Hypotension in Volume- or Salt-Depleted Patients
• Impaired Renal Function
• Hypersensitivity Reactions
• Acute Myopia and Secondary Angle-Closure Glaucoma
• Systemic Lupus Erythematosus
• Sprue-Like Enteropathy

What special precautions should I follow?

• In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with Benicar HCT. If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
• Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on Benicar HCT.
• Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.
• Benicar HCT contains hydrochlorothiazide which can cause hypokalemia and hyponatremia.
• Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.
• Hyperuricemia may occur or frank gout may be precipitated in patients receiving thiazide therapy.
• Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels.
• Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled.
• Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.
• Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Consider discontinuation of Benicar HCT in cases where no other etiology is identified.
• Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.
• Advise patients that [[]]lightheadedness can occur, especially during the first days of therapy, and to report this symptom to a healthcare provider. Inform patients that dehydration from inadequate fluid intake, excessive perspiration, vomiting, or diarrhea may lead to an excessive fall in blood pressure. If syncope occurs advise patients, to contact their healthcare provider.

What to do in case of emergency/overdose?

Symptoms of overdosage may include: Olmesartan medoxomil overdose:

• hypotension
• tachycardia
• bradycardia

Hydrochlorothiazide overdose:

• hypokalemia
• hypochloremia
• hyponatremia
• dehydration
• cardiac arrhythmias

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• If symptomatic hypotension should occur, supportive treatment should be initiated. The dialyzability of olmesartan is unknown.
• The degree to which hydrochlorothiazide is removed by hemodialysis has not been established.

Can this medicine be used in pregnancy?

• Pregnancy Category D.
• Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity, and death.
• When pregnancy is detected, discontinue Benicar HCT as soon as possible.

Can this medicine be used in children?

• Safety and effectiveness of Benicar HCT in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active:

• OLMESARTAN MEDOXOMIL
• HYDROCHLOROTHIAZIDE

Inactives:

• HYDROXYPROPYL CELLULOSE
• HYPROMELLOSE, UNSPECIFIED
• LACTOSE MONOHYDRATE
• LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• FERRIC OXIDE RED
• TALC
• TITANIUM DIOXIDE
• FERRIC OXIDE YELLOW

Who manufactures and distributes this medicine?

• Manufactured for Daiichi Sankyo, Inc., Basking Ridge, NJ

What should I know about storage and disposal of this medication?

• Store at 20-25ºC (68-77ºF).

• Dailymed label info on Olmesartan medoxomil and hydrochlorothiazide
• FDA Olmesartan medoxomil and hydrochlorothiazide